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U.S. Department of Health and Human Services

Class 2 Device Recall ASP1021LipoTower with Aspiration Pump and Tumescent Pump

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 Class 2 Device Recall ASP1021LipoTower with Aspiration Pump and Tumescent Pumpsee related information
Date Initiated by FirmJune 12, 2015
Date PostedSeptember 30, 2015
Recall Status1 Terminated 3 on May 23, 2016
Recall NumberZ-2822-2015
Recall Event ID 72106
510(K)NumberK113128 
Product Classification System, suction, lipoplasty - Product Code MUU
ProductASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
Code Information Serial numbers 14101241, 4091238, 15011258, 15051279, 13101158, 15051275, 14021190, 12121111, 15051274, 14071221, 13081149, 13031123, 14021187, 14121254, 14081231, 13121173, 13111167, 13101164, 13121172, 14091234, 14111248, 14031196, 13061142, 15031264, 13121171, 13021116, 15051276, 13041131, 13101160, 14051210, 15041271, 14071222, 14051208, 15021260, 13111166, 13101163, 14111246, 13111168, 13101158, 14061212, 13081152, 13121177, 13061145, 15051280, 15061283, 14041200, 13021114, 14011184, 14031193, 13111165, 14011182, 14111249, 14101242, 14011181, 15041272, 13101156, 13041126, 14101240, 14021188, 12111108, 13061141, 12121112, 13061140, 13041128, 13081150, 14031195, 15051281, 14031197, 14081228, 14101243, 14031199, 14081232, 14071226, 13081148, 14111244, 14091238, 15051279, 13091154, 13121179, 14121252, 15041268, 14071225, 14071223, 15031266, 13031122, 13061144, 14021186, 14091233, 13101161, 14031194, 15041273, 13121170, 13021120, 13011113, 13121174, 14041201, 15021261, 14011183, 13061143, 13121175, 15021262, 15011259, 13101157, 14071227, 13091155, 13111169, 14121251, 14061211, 14071216, 14041207, 13041124, 14021189, 14011185, 14031198, 12101105, 14071224, 14041203, 14071220, 13051132, 14091239, 15041269, 14051209, 15021263, 15011257, 13081147, 13031121, 14101241, 15011258, 13041125, 13081151, 13101159, 13121176, 12121109, 14061213, 13121178

13101162, 14111245, 13061138, 14081229, 14021192, 14091237, 14121253, 13061139, 14121255, 15051278, 15051277, 14071217, 15011256, 13021118, 13071146, 13051135, 13051136, 13051137, 14071219, 14081230, 13041127, 12101106, 14061215, 12101107, 14061214, 15041267, 14041206, 14041202, 13041130, 13041129, 14021191, 13051133, 13051134, 14011180, 14091235, 14091236, 14111247, and 14111250.
Recalling Firm/
Manufacturer		 MicroAire Surgical Instruments, LLC
3590 Grand Forks Blvd
Charlottesville VA 22911-9006
For Additional Information ContactJordan Quiroz
434-975-8000
Manufacturer Reason
for Recall		There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
FDA Determined
Cause 2		Device Design
ActionThe firm has issued FDA recall letters to all consignees. The letter have been sent out by UPS to expedite the delivery.
Quantity in Commerce168, ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUU
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